Conflicts of Interest: More Questions than Answers

It was fitting that this year's TCT conference included a session on physician/industry conflicts of interest since this has been a hot topic recently in the press, and because TCT is probably the most industry-focused of all the major clinical conferences. Not surprisingly, the panel of physicians raised more questions than answers about both individual and institutional conflicts and how they should be handled.

It was fitting that this year's Transcatheter Cardiovascular Therapeutics (TCT) conference included a session on physician/industry conflicts of interest (COI). The panel was not only timely, since this has been a hot topic recently for both pharmaceutical and medical device companies, but well-suited for this meeting since TCT is probably the most industry-focused of all the major clinical conferences. This is due largely to the nature of the specialty and to the significant product advances that have occurred in this area.

Interventional cardiologists are among the most eager adopters of new technology, and the specialty relies heavily on evidence-based medicine that often enables a new device to establish a foothold in the market by demonstrating superior clinical performance. These advances have been brought about through close working relationships between product companies and physicians that have been responsible for many of the major device breakthroughs of the last 20 years. These relationships, however, are coming under closer scrutiny, and physicians and the industry are wrestling with how to avoid problematic conflicts while not inhibiting product innovation.

The most commonly suggested answer to the conflicts issue is increased disclosure. Indeed, TCT emphasizes the need for physician disclosure to a greater extent than any other major clinical conference—requiring both podium speakers and physicians performing live cases being transmitted to the meeting to include a slide listing their conflicts. The conference organizers—the Cardiovascular Research Foundation (CRF)—also puts together a booklet listing all of the presenters' conflicts, which is widely distributed throughout the meeting.

At the COI panel, however, Donald Baim, MD, newly named chief medical and scientific officer of Boston Scientific Corp. , suggested that the device industry has placed entirely too much emphasis on disclosure as the solution to the conflicts issue in determining the threshold for whether a physician is "tainted." "In terms of managing that conflict, disclosure is almost never enough. The way to deal with this issue at meetings like this is through debate, which means having opposing views or different devices presented in close proximity to one another," he says.

In Baim's view, there are two other "D's" that are under-utilized in dealing with the conflicts issue: divestiture and distance. "If you really want to effectively avoid conflicts, we should look more closely at requiring divestiture in certain circumstances," he suggests.

Further, he believes that physicians need to make sure that they distance themselves from certain situations to avoid any appearance of conflict. "A person who has a significant financial conflict should not be adjudicating data on adverse outcomes, should not be compiling clinical study statistics, should not be deciding if the study does or does not continue, and quite possibly should not be obtaining informed consent from patients because the patients expect us to be acting in their best interest—that's the nature of the patient-physician relationship," he says.

Peter Fitzgerald, MD, PhD, of Stanford University 's School of Medicine, echoed Baim's view of the need to manage conflicts beyond just disclosure. Fitzgerald pointed out that he stopped taking care of cath lab patients "because of the potential appearance that there might be a conflict with some of the companies and devices that I'm involved with." In his view, a physician who is working with a company on a device and, for example, is the principal investigator in a clinical trial, should not be obtaining informed consent from patients to utilize that product.

The question of how academic medical centers, whose physicians are often heavily involved in clinical trials and device development, handle the issue of conflicts sparked heated discussion. Fitzgerald emphasized the need to inform the next generation of physicians about this issue by making sure that conflicts of interest is a subject covered in medical schools, which is not being currently done on a consistent basis.

In addition to conflicts involving physicians, there is an issue of potential conflicts involving the institutions themselves. All of the major academic medical centers own rights to intellectual property developed by their physicians and researchers that has been licensed to product companies and on which the institutions receive licensing royalties. Should the institutions disclose to patients that the hospital has a financial interest in the device that is about to be implanted in them?

Richard Popp, MD, of Stanford, who moderated the session, pointed out that Stanford has adopted a policy to address that specific situation. When a company licenses IP from Stanford that the institution would otherwise receive royalties on, Stanford either requires—by contract—that the company pay a lump sum to the university to acquire rights to that IP, thus negating a licensing relationship that generates an ongoing revenue stream based on product utilization; or Stanford foregoes taking any equity in that company.

It was clear from the discussion that, while certain institutions such as Stanford and the Mayo Clinic are acutely aware of the conflicts issue and are aggressively developing policies to address it, many other institutions are not prepared to deal with this problem. Michael Callahan, an attorney who represents major medical centers, noted that "the question of institutional conflicts is going to become a bigger issue for board members, department chairs, and anyone else who is seen as an agent of the institution."

Callahan predicts that we will start to see the establishment of specific COI committees, and suggests that institutional review boards (IRBs) will also take a more active role in compliance. "One thing is for sure: you don't want the government to be your compliance officer," he cautioned. "If an existing financial relationship between a physician and a product company is not disclosed to a patient in a situation where that device is used, you don't want that coming out for the first time in front of a jury at trial."

While many of the COI issues apply across the board to medical device and pharmaceutical companies, there is also an important distinction in that devices require the expertise of a physician in order to maximize their effectiveness, as opposed to simply taking a pill. This raises the issue of how involved a physician who has helped develop a particular device should be in the early stages of utilizing that product with patients, particularly since that physician is often the most skilled in using that device.

"We should not be afraid of this issue because that is how we will continue to improve patient care," said Peter Fitzgerald. Richard Popp agreed, adding, "The test should be whether what the physician is doing is best for the patient. I don't think we want the first physicians using a device to be those who don't know how best to operate it." Surgeon/entrepreneur Thomas J. Fogarty, MD went so far as to suggest that it would be a violation of a doctor's Hippocratic oath to prevent the physician who best knows how to use a device from treating patients with that product.

The TCT conference and its directors, Martin Leon, MD, and Gregg Stone, MD, both from Columbia University Medical Center, are lightning rods for criticism on the conflicts of interest issue. Leon explains that, in organizing TCT, the way he and Stone have attempted to deal with this issue—in addition to the emphasis placed on disclosure--is by ensuring that as much as possible of the actual planning of the meeting content and live cases is done by independent bodies. "We are extremely sensitive to the issue of conflicts, and we keep that very much in mind as we try to maintain both the independence and scientific credibility of the meeting," he said.

Stone noted that TCT is actually "ahead of the curve" in the way clinical conferences address COI. "We are the first organization that I'm aware of that insists that speakers who do not provide disclosure information will not participate in the conference, and that also applies to physicians doing live cases," he added.

Looking to stir things up, Stone termed the current media coverage of conflict of interest "low hanging fruit that is easy to write about," and suggested that the press is really missing the tougher, more important parts of the COI debate. In his view, there are more significant conflicts with what physicians must do in terms of publishing and conducting clinical trials in order to advance at their institutions.

According to Stone, more attention should also be paid to physician malfeasance, especially since most proven cases occur in an academic setting. "And let me be very provocative," he said, "and point out that the ultimate medical conflict of interest in the US occurs from physicians being paid to treat patients, and ordering tests and using products in that process."

Not surprisingly, the discussion raised more questions than answers, but one common fear among the physicians on the panel was that, in the rush to address the conflicts issue, the pendulum would swing too far because the result would be to diminish the level of innovation and, with that, the quality of care being delivered to patients. Gregg Stone cautioned, "We're at a time now where patient outcomes are getting so much better because we are making such incredible advances in medical care. We need to keep our eyes on the ball to make sure that we're not using a shotgun to address a problem that should be better dealt with in a more focused fashion so we don't run the risk of impeding that progress."

Stephen Levin